Trial Outcomes & Findings for A Long-term Study on the Side Effects of TRADIANCE in Japanese Patients With Type 2 Diabetes (NCT NCT03761797)
NCT ID: NCT03761797
Last Updated: 2023-01-23
Results Overview
The number of participants with adverse drug reactions is reported.
Recruitment status
COMPLETED
Target enrollment
1164 participants
Primary outcome timeframe
From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Results posted on
2023-01-23
Participant Flow
This was a non-interventional study based on newly collect data of patients under routine care to confirm safety of TRADIANCE® Combination Tablets AP and BP in real-world setting in Japanese patients with Type 2 Diabetes mellitus (T2DM).
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
All Patients With Type 2 Diabetes Mellitus
TRADIANCE® Combination Tablet AP or BP (fixed dose combination of empagliflozin and linagliptin) were administered orally once daily for patients with type 2 Diabetes Mellitus (T2DM). The TRADIANCE® Combination Tablet AP contains 10 milligrams (mg) empagliflozin and 5 mg linagliptin, while Tablet BP contains 25 mg empagliflozin and 5 mg linagliptin. Patients were followed up to 52 weeks.
|
|---|---|
|
Overall Study
STARTED
|
1164
|
|
Overall Study
Safety Set
|
1146
|
|
Overall Study
COMPLETED
|
1025
|
|
Overall Study
NOT COMPLETED
|
139
|
Reasons for withdrawal
| Measure |
All Patients With Type 2 Diabetes Mellitus
TRADIANCE® Combination Tablet AP or BP (fixed dose combination of empagliflozin and linagliptin) were administered orally once daily for patients with type 2 Diabetes Mellitus (T2DM). The TRADIANCE® Combination Tablet AP contains 10 milligrams (mg) empagliflozin and 5 mg linagliptin, while Tablet BP contains 25 mg empagliflozin and 5 mg linagliptin. Patients were followed up to 52 weeks.
|
|---|---|
|
Overall Study
Changing hospital
|
11
|
|
Overall Study
Improvement/remission
|
6
|
|
Overall Study
Withdrawal by Subject
|
19
|
|
Overall Study
Lost to Follow-up
|
33
|
|
Overall Study
Adverse Event
|
37
|
|
Overall Study
Case report form (CRF) not collected
|
5
|
|
Overall Study
No patient visit after entry
|
13
|
|
Overall Study
Switch to other diabetes medication
|
10
|
|
Overall Study
Prevention for recurrence of cystitis
|
1
|
|
Overall Study
Postoperative therapy of esophageal cancer
|
1
|
|
Overall Study
Insufficient effectives
|
2
|
|
Overall Study
Excessive alcohol intake
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Patients With Type 2 Diabetes Mellitus
n=1146 Participants
TRADIANCE® Combination Tablet AP or BP (fixed dose combination of empagliflozin and linagliptin) were administered orally once daily for patients with type 2 Diabetes Mellitus (T2DM). The TRADIANCE® Combination Tablet AP contains 10 milligrams (mg) empagliflozin and 5 mg linagliptin, while Tablet BP contains 25 mg empagliflozin and 5 mg linagliptin. Patients were followed up to 52 weeks.
|
|---|---|
|
Age, Continuous
|
63.8 Years
STANDARD_DEVIATION 12.8 • n=1146 Participants
|
|
Sex: Female, Male
Female
|
394 Participants
n=1146 Participants
|
|
Sex: Female, Male
Male
|
752 Participants
n=1146 Participants
|
PRIMARY outcome
Timeframe: From first dose of study medication until last dose + 7 days, up to 102.1 weeks.Population: Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
The number of participants with adverse drug reactions is reported.
Outcome measures
| Measure |
All Patients With Type 2 Diabetes Mellitus
n=1146 Participants
TRADIANCE® Combination Tablet AP or BP (fixed dose combination of empagliflozin and linagliptin) were administered orally once daily for patients with type 2 Diabetes Mellitus (T2DM). The TRADIANCE® Combination Tablet AP contains 10 milligrams (mg) empagliflozin and 5 mg linagliptin, while Tablet BP contains 25 mg empagliflozin and 5 mg linagliptin. Patients were followed up to 52 weeks.
|
|---|---|
|
Number of Participants With Adverse Drug Reactions (ADRs)
|
32 Participants
|
Adverse Events
All Patients With Type 2 Diabetes Mellitus
Serious events: 40 serious events
Other events: 0 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
All Patients With Type 2 Diabetes Mellitus
n=1146 participants at risk
TRADIANCE® Combination Tablet AP or BP (fixed dose combination of empagliflozin and linagliptin) were administered orally once daily for patients with type 2 Diabetes Mellitus (T2DM). The TRADIANCE® Combination Tablet AP contains 10 milligrams (mg) empagliflozin and 5 mg linagliptin, while Tablet BP contains 25 mg empagliflozin and 5 mg linagliptin. Patients were followed up to 52 weeks.
|
|---|---|
|
Infections and infestations
Infective spondylitis
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Infections and infestations
Influenza
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Infections and infestations
Pyelonephritis
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Infections and infestations
Pyoderma
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Cardiac disorders
Myocardial infarction
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic interstitial pneumonia
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
General disorders
Death
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Injury, poisoning and procedural complications
Fall
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Infections and infestations
Pneumonia bacterial
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Infections and infestations
Viral infection
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Nervous system disorders
Cerebral infarction
|
0.35%
4/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Nervous system disorders
Thalamic infarction
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Cardiac disorders
Angina pectoris
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Cardiac disorders
Angina unstable
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Cardiac disorders
Cardiac failure
|
0.17%
2/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Cardiac disorders
Myocarditis
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.17%
2/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.17%
2/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Scrotal cancer
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.09%
1/1146 • From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place